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WO2023025437A1 - Dispositif de préparation d'un produit pharmaceutique, d'un complément alimentaire ou d'un produit cosmétique - Google Patents

Dispositif de préparation d'un produit pharmaceutique, d'un complément alimentaire ou d'un produit cosmétique Download PDF

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Publication number
WO2023025437A1
WO2023025437A1 PCT/EP2022/067953 EP2022067953W WO2023025437A1 WO 2023025437 A1 WO2023025437 A1 WO 2023025437A1 EP 2022067953 W EP2022067953 W EP 2022067953W WO 2023025437 A1 WO2023025437 A1 WO 2023025437A1
Authority
WO
WIPO (PCT)
Prior art keywords
substance
cavity
shell
station
supply line
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2022/067953
Other languages
German (de)
English (en)
Inventor
Guido Knobel
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to EP22743460.2A priority Critical patent/EP4391986A1/fr
Priority to US18/686,106 priority patent/US20240350366A1/en
Publication of WO2023025437A1 publication Critical patent/WO2023025437A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/06—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of pills, lozenges or dragees
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035—Blister-type containers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B5/00—Packaging individual articles in containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, jars
    • B65B5/10—Filling containers or receptacles progressively or in stages by introducing successive articles, or layers of articles
    • B65B5/101—Filling containers or receptacles progressively or in stages by introducing successive articles, or layers of articles by gravity
    • B65B5/103—Filling containers or receptacles progressively or in stages by introducing successive articles, or layers of articles by gravity for packaging pills or tablets

Definitions

  • the invention relates to a device for producing a pharmaceutical, food supplement or cosmetic from at least one active substance, with the production taking place in a filling station in at least one cavity of a mould, and a method for this.
  • compositions are now generally manufactured industrially in large numbers in appropriate systems. These are, for example, tablets that are always manufactured, filled and packaged according to the same recipe. Today, however, the desire is getting louder again that such products are manufactured according to special recipes, for example if more medicinal herbs or the like and recipes based on old knowledge are to be used again. It will also be desirable in the future to adapt the composition of formulations depending on the patient or his illness. Of course, this is not possible on an industrial scale, but can only be done with machines that make it possible to produce a smaller number of tablets.
  • DE 10 2007 051 757 A1 describes a method for the automatic production of patient-specific dosed pharmaceutical preparations, but a corresponding device for this is not offered. The same applies to DE 10 2014 105 989 A1.
  • WO 2020/099387 A describes a tablet press for the automated production of a predeterminable number of individualized tablets, which has a very complicated structure and is very complicated to handle.
  • the object of the present invention is to create a device and a method of the above-mentioned type with which patient-specific pharmaceuticals, food supplements or cosmetics can be produced in a simple manner on a small scale by persons authorized to do so.
  • a supply line for a substance for a shell or for a binder and at least one further supply line for the active substance of the cavity or the last-mentioned supply lines are assigned directly to a receiving container.
  • Tablets in particular, but liquids or other forms of administration are also suitable as the form of administration according to the present invention. If only tablets are discussed below, then of course the corresponding liquids or other dosage forms are also covered by the inventive idea. If only pharmaceuticals or a pharmaceutical substance are mentioned below, this also includes food supplements or cosmetics and the corresponding active substances required for them. They should always be included in the term.
  • the filling medium also covers a wide range between liquid and solid, for example a consistency such as honey or batter is possible.
  • the system according to the invention can also fill aerated masses of any type from micro to several millimeters in size.
  • the ventilation can consist of gases of any kind, for example. Filling media mixed with solids and/or gassing are also possible. It is also within the scope of the invention for foamed masses to be filled, these can also be mixed with solids and/or gassing.
  • the supply line(s) for the active substances to open directly into a container, for example a small bottle or a powder can.
  • the pharmaceutical can then be taken directly from this container by the consumer.
  • the scope of the invention also includes the production of the pharmaceutical in tablet form. So that the tablet has sufficient rigidity, it can be conceivable that a binder is added to the pharmaceutical substance or substances.
  • the invention encompasses the production of tablets with a shell in which the pharmaceutical substance is contained.
  • This The design makes it possible for the tablet to be produced in a single shot, this is also known as the one-shot process.
  • a simple form of the one-shot process for food is presented, for example, in WO 94/02027.
  • it is also known in confectionery machine construction.
  • chocolate for the outer shell is poured through a nozzle into a cavity and the contents of the praline are filled into this forming chocolate shell with another nozzle, so that a closed praline is finally produced.
  • the present inventive device provides a substance supply line for the sheath, which is arranged around the pharmaceutical substance supply line. This means that the outlets of both supply lines are arranged in or above the cavity, so that now only the addition of the substances for the shell and the addition of the pharmaceutical substance has to be controlled.
  • a plurality of feed lines for the pharmaceutical substances are provided. These should first get into a mixing chamber so that a homogeneous mixture of the active substances can be produced before it is filled into the cavity.
  • the main idea is to produce the pharmaceutical substances in their pure form in cartridges and to offer them for use with the present device. This means that the user, for example a pharmacist, should stock a plurality of cartridges with different pharmaceutical substances. Depending on the desired recipe for the tablet, he can then assemble the cartridges in the device so that the recipe is then generated in the mixing chamber.
  • the substance for the shell is also provided in a cartridge
  • cartridges with different substances for one case can also be offered.
  • the pharmaceutical substances can be present in the cartridge in powder form, in liquid form or in meltable form.
  • melting is only possible by means of heat, which is why, according to the invention, the corresponding cartridge is also assigned a heating device.
  • These individual heating devices can preferably also be controlled individually. For this reason, the cartridges are spaced apart so that the temperature of adjacent cartridges cannot be influenced.
  • the substance is discharged from the cartridge by a piston which pressurizes the substance in the cartridge.
  • the piston is preferably connected via a ram to a drive which can apply pressure to the ram and thus to the piston.
  • this drive is designed should be of secondary importance. Many possibilities are conceivable here, which can be electric, hydraulic, pneumatic or manual drives. In any case, it would be advisable to detachably connect the plunger to the drive so that the cartridges can be easily replaced.
  • An important point of the invention lies in the fact that the ram is not only one direction for squeezing the substances out of the cartridges, but also in the opposite direction. As soon as the cavity is sufficiently filled with the substances, the plunger or plungers in the cartridge should be pulled back slightly to prevent the substance from dripping into the cavity.
  • Such a cooling station can have any configuration.
  • the blister pack runs through a labeling station where all the necessary data is applied to the blister pack.
  • the transport of the form from the filling station to the sealing station, cooling station and marking station takes place on a single conveyor belt, which facilitates manufacture.
  • the present invention also includes a method for producing tablets from at least one pharmaceutical substance in a shell, wherein the production takes place in a filling station in at least one cavity of a mold, wherein a supply line for a substance for the shell and at least one further supply line for the pharmaceutical substance to the cavity takes place at least partially simultaneously.
  • a method for producing tablets from at least one pharmaceutical substance in a shell wherein the production takes place in a filling station in at least one cavity of a mold, wherein a supply line for a substance for the shell and at least one further supply line for the pharmaceutical substance to the cavity takes place at least partially simultaneously.
  • a plurality of pharmaceutical substances are to be brought into tablet form, they are mixed in a mixing chamber according to the method according to the invention and the substance for the shell of the cavity is fed in at the same time. This ensures that the substance for the shell first forms a base and, if necessary, walls for receiving the mixture of pharmaceutical substances. After the pharmaceutical substances have been supplied to the cavity, the substance for the shell is supplied until the substance for the shell envelops the pharmaceutical substance. Only then is the tablet finished and ready for use.
  • FIG. 1 shows a perspective view of a device according to the invention for producing tablets
  • FIG. 2 shows a front view of the device according to FIG. 1 with the protective wall removed;
  • FIG. 3 shows a side view of part of the device according to FIG. 2;
  • FIG. 4 shows an enlarged and opened detail from the front view of the device according to FIG. 2;
  • FIG. 5 shows a side view of a further part of the device according to the invention according to FIG.
  • a device P according to the invention for producing tablets always has a filling station 1 . This can be followed by a sealing station 2 and/or a cooling station 3 and/or a marking station 4 .
  • the stations 1, 2, 3 and 4 are connected to one another via a transport device 5, with which molds 6 with cavities 7 can be transported through the stations.
  • each cartridge 9, 10.1 to 10.3 is closed by a cover 11 and is surrounded by a jacket 12.
  • heating packages 13.1 and 13.2, which are supplied with electrical energy via lines 14, are located in front of and behind the jacket 12.
  • These heating packages 13.1 and 13.2 are monitored by means of temperature sensors 12.01 and 12.02.
  • a sensor 11.1 is provided on the cover 11, which is used to identify the cartridge. This is preferably an RFID sensor
  • These brackets 18 make a releasable connection with a drive train 19 which is vertically movable. The detachable connection can also be released manually by a button 20.
  • Each drive train 19 is only shown schematically here, connected to a drive 21.1, 21.2, which makes it possible for each drive train 19 to be moved horizontally separately or for all drive trains to be moved together.
  • the drive 21.1 can be a crank drive, the horizontal shaft 22 of which can be moved up and down via guide sleeves 23.1 and 23.2 along guide columns 24.1 and 24.2 on a traverse frame 25.
  • a distributor block 26 is provided under the cartridges 9 or 10.1 to 10.3, which is again shown in more detail in FIG. 4 and is also monitored by a sensor, such as an RFID sensor 26.1 are each connected to a mixing chamber 38 via a supply line 27.1 to 27.3. From this mixing chamber 38 leads a Pressure line 29 to the cavity 7, wherein mixed substances can be entered into the cavity 7 from the pressure line 29.
  • a supply line 30 is provided in the distributor block 26, which is connected to the cartridge 9, which contains a substance for the coating of the tablet.
  • This supply line 30 is connected to a jacket tube 31 which surrounds the pressure line 29 , the substance for the jacket being fed to the cavity 7 between the jacket tube 31 and the pressure line 29 .
  • the task for, for example, a pharmacist is to produce a tablet with a predetermined pharmaceutical substance in a shell for a customer.
  • the corresponding pharmaceutical base substances are in different cartridges 10.1 to 10.3, which are marked according to their content.
  • an RFID chip Radio Frequency Identification
  • the pharmacist takes the appropriate cartridges 10.1 to 10.3 from a store and inserts them into the filling station 1, being surrounded by the jacket 12 and located between the heating packages 13.1 and 13.2.
  • a corresponding reading device behind the cartridges 10.1 to 10.3 recognizes which cartridges contain which pharmaceutical substances and whether these cartridges are correct.
  • a corresponding neck 32 is also inserted in a sealed manner into the distributor block 26, so that this neck 32 comes into flow contact with the respective supply line 27.1 to 27.3.
  • the cartridge 9 with the substance for the casing is also inserted into the filling station 1 . Its neck also comes into operative contact with the supply line 30, which leads to the cavity.
  • each cartridge 9 or 10.1 to 10.3 there is a piston which projects out of the cartridge with a corresponding plunger 16, the abutment 17 of which is brought into operative connection with the clamps 18. That is, the clamps 18 are open so that the abutment 17 can engage between the clamps. Thereafter, the clamps 18 are closed, gripping under the abutment 17 .
  • a connection between the cartridges 9 and 10.1 to 10.3 and the drive 21 is now established.
  • the substances are filled into the cavity 7. This is done using the so-called one-shot method, which is known, for example, from WO 94/02027 or DE 197 32 593 C2 from chocolate production.
  • pressure is applied via the corresponding plunger 16 to the piston 15 of the cartridge 9 with the substance for the shell.
  • substance for the shell is filled into the cavity via the supply line 30 and the space between the shell tube 31 and the pressure line 29, so that a bottom is formed.
  • the pharmaceutical substances are fed via the supply lines 27.1, 27.2 and 27.3 to the mixing chamber 38, where these substances are mixed and added to the cavity via the pressure line 29.
  • a wall for the tablet is pulled up on the side of the cavity while it is still being fed. Then the supply of pharmaceutical substance is stopped and the shell is closed by further supply of shell substance.
  • the detachable connection between the plunger 16 and the brackets 18 is mainly used to allow withdrawal of the plunger 16 after the end of the supply of the corresponding substance, which has the result that slightly substances in the pressure line 29 and the space between Pressure line 29 and cladding tube 31 is withdrawn, so that dripping of the substance is prevented.
  • This sealing station 2 primarily has a film 33 which engages under a sealing tool 34 and is guided over the mold. When the sealing tool 34 is lowered, the film 33 is sealed onto the mold 6, so that the cavities with the tablets produced are now closed.
  • this sealing tool 34 can also be designed to be exchangeable, so that different shapes can be accommodated. Furthermore, this sealing tool can also be designed as a punching tool at the same time, so that the film is punched out from a film strip 33 in the area of the mold.
  • the form of the cooling station 3 is fed via the transport device 5, where the entire form is largely cooled.
  • the marking station 4 that follows, all the necessary data is applied to the form, as well as a readout of data that has been entered into the RFID chip in the individual stations, for example.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Basic Packing Technique (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne un dispositif de préparation d'un produit pharmaceutique, d'un complément alimentaire ou d'un produit cosmétique à partir d'au moins une substance active, la préparation s'effectuant dans une station de remplissage (1) dans au moins une cavité (7) d'un moule (6), une conduite d'alimentation (30) pour une substance pour une enveloppe et/ou un liant et au moins une conduite d'alimentation supplémentaire (27.1 à 27.3, 29) pour la substance active de la cavité (7) ou les conduites d'alimentation (27.1-27.3) mentionnées ci-dessus devant être directement attribuées à un contenant de réception.
PCT/EP2022/067953 2021-08-25 2022-06-29 Dispositif de préparation d'un produit pharmaceutique, d'un complément alimentaire ou d'un produit cosmétique Ceased WO2023025437A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP22743460.2A EP4391986A1 (fr) 2021-08-25 2022-06-29 Dispositif de préparation d'un produit pharmaceutique, d'un complément alimentaire ou d'un produit cosmétique
US18/686,106 US20240350366A1 (en) 2021-08-25 2022-06-29 Device for producing a pharmaceutical, dietary supplement or cosmetic

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102021122015.7 2021-08-25
DE102021122015 2021-08-25

Publications (1)

Publication Number Publication Date
WO2023025437A1 true WO2023025437A1 (fr) 2023-03-02

Family

ID=82594746

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2022/067953 Ceased WO2023025437A1 (fr) 2021-08-25 2022-06-29 Dispositif de préparation d'un produit pharmaceutique, d'un complément alimentaire ou d'un produit cosmétique

Country Status (3)

Country Link
US (1) US20240350366A1 (fr)
EP (1) EP4391986A1 (fr)
WO (1) WO2023025437A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102024200618A1 (de) * 2024-01-24 2025-07-24 Fs Innotech Gmbh Dosiervorrichtung

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0227050A1 (fr) * 1985-12-19 1987-07-01 Capsoid Pharma GmbH Procédé pour la préparation de doses unitaires d'administration et les formes d'administration obtenues par ce procédé
WO1994002027A1 (fr) 1992-07-22 1994-02-03 Unilever Plc Buse et procede d'extrusion de produits alimentaires
DE19732593C2 (de) 1997-03-21 1999-07-29 Kmb Produktions Ag Düse zum Herstellen eines Verzehrgutes
DE10345933B4 (de) * 2003-10-02 2007-05-16 Winkler Und Duennebier Sueswar Düse zum Dosieren gefüllter Süßwarenartikel in eine Gießform
DE102007051757A1 (de) 2007-10-30 2009-05-07 Ecker, Felix, Prof. Dr. Verfahren zur automatischen Herstellung von patientenindividuell dosierten pharmazeutischen Zubereitungen
DE102009056738A1 (de) * 2009-12-04 2011-06-09 Pfeifer & Langen Kommanditgesellschaft Lebensmittelprodukt sowie Verfahren zur Herstellung eines Lebensmittelproduktes
DE102014105989A1 (de) 2014-04-29 2015-10-29 Gako International Gmbh Apotheken-Rezepturherstellungssystem und Apotheken-Rezepturherstellungsverfahren zum Herstellen von pharmazeutischen Individualrezepturen
WO2019165278A1 (fr) * 2018-02-26 2019-08-29 Fuisz Richard C Emballage, système et procédés de garde et de contrôle de médicaments
WO2020099387A1 (fr) 2018-11-12 2020-05-22 4K Global Holding UG (haftungsbeschränkt) Procédé de fabrication automatisée de comprimés individualisés et presse à comprimés pour la fabrication automatisée de comprimés individualisés
US20200188307A1 (en) * 2017-05-11 2020-06-18 Pharmaprint Limited Llc System and method for producing pharmacutical objects via 3d printing

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CN103596551B (zh) * 2011-06-08 2017-02-22 Lts勒曼治疗系统股份公司 含有用于掩味的离子交换树脂的食用口服条或糯米纸囊剂型
IL312865B2 (en) * 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
US10238600B2 (en) * 2017-04-13 2019-03-26 Richard C. Fuisz Package, system and methods for custody and control of drugs, and method and composition for making an oral soluble film, containing at least one active agent
US11318107B2 (en) * 2019-02-22 2022-05-03 Avior, Inc. Pharmaceutical active-containing film delivery device for oral transmucosal administration

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0227050A1 (fr) * 1985-12-19 1987-07-01 Capsoid Pharma GmbH Procédé pour la préparation de doses unitaires d'administration et les formes d'administration obtenues par ce procédé
WO1994002027A1 (fr) 1992-07-22 1994-02-03 Unilever Plc Buse et procede d'extrusion de produits alimentaires
DE19732593C2 (de) 1997-03-21 1999-07-29 Kmb Produktions Ag Düse zum Herstellen eines Verzehrgutes
DE10345933B4 (de) * 2003-10-02 2007-05-16 Winkler Und Duennebier Sueswar Düse zum Dosieren gefüllter Süßwarenartikel in eine Gießform
DE102007051757A1 (de) 2007-10-30 2009-05-07 Ecker, Felix, Prof. Dr. Verfahren zur automatischen Herstellung von patientenindividuell dosierten pharmazeutischen Zubereitungen
DE102009056738A1 (de) * 2009-12-04 2011-06-09 Pfeifer & Langen Kommanditgesellschaft Lebensmittelprodukt sowie Verfahren zur Herstellung eines Lebensmittelproduktes
DE102014105989A1 (de) 2014-04-29 2015-10-29 Gako International Gmbh Apotheken-Rezepturherstellungssystem und Apotheken-Rezepturherstellungsverfahren zum Herstellen von pharmazeutischen Individualrezepturen
US20200188307A1 (en) * 2017-05-11 2020-06-18 Pharmaprint Limited Llc System and method for producing pharmacutical objects via 3d printing
WO2019165278A1 (fr) * 2018-02-26 2019-08-29 Fuisz Richard C Emballage, système et procédés de garde et de contrôle de médicaments
WO2020099387A1 (fr) 2018-11-12 2020-05-22 4K Global Holding UG (haftungsbeschränkt) Procédé de fabrication automatisée de comprimés individualisés et presse à comprimés pour la fabrication automatisée de comprimés individualisés

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102024200618A1 (de) * 2024-01-24 2025-07-24 Fs Innotech Gmbh Dosiervorrichtung

Also Published As

Publication number Publication date
EP4391986A1 (fr) 2024-07-03
US20240350366A1 (en) 2024-10-24

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